MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND SORIN HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Endocarditis (1834); Fever (1858); Renal Failure (2041); Malaise (2359)

Event Date 10/16/2015

Event Type  Injury  

Manufacturer Narrative

The model and serial number were not provided, and the unique identifier (udi) number could not be determined.This information will be provided in a supplemental report if and when made available.The user report did not contain information regarding the reporting facility.This information will be provided in a supplemental report if and when made available.As the model number was not provided, the 510(k) number could not be determined.This information will be provided in a supplemental report if and when made available.As the serial number was not provided, the date of manufacture could not be determined.This information will be provided in a supplemental report if and when made available.Sorin group (b)(4) manufactures the sorin heater-cooler system 3t.The location where this incident occurred is unknown.This medwatch report is being filed on behalf of sorin group (b)(4).As no device information or contact information for the facility or for the initial reporter was provided in the user medwatch report, sorin group (b)(4) is unable to perform any follow-up with the customer regarding this event at this time.A review of existing complaints did not identify any event that matched the description provided in the user report.No further investigation is possible.In the event of receipt of new information, a supplemental report will be provided.

Event Description

On october 11, 2016, sorin group (b)(4) received a user medwatch report (mw5064988) stating that a patient was admitted to the hospital in 2015 for coronary artery bypass grafting and a valve replacement.The patient was discharged from the hospital following the procedure and presented in 2016 with complaints of 6 weeks of fevers, night sweats and malaise.The patient was diagnosed with endocarditis and renal failure requiring dialysis.Patient cultures were taken, which tested positive for non-tuberculous mycobacterium (ntm).

• Brand Name: SORIN HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich, 80939 ; GM 80939
• Manufacturer (Section G): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich, 80939 ; GM 80939
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6067009
• MDR Text Key: 58766554
• Report Number: 9611109-2016-00716
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Date Manufacturer Received: 10/11/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening